Carcinoma, Pancreatic Ductal
Conditions
Keywords
BR-PDAC, Pancreatic Ductal Adenocarcinoma, Borderline Resectable, CA 19-9, Anatomical
Brief summary
Radical surgical resection is the only curative treatment option for pancreatic cancer, but borderline resectable tumors have a high probability of incomplete exeresis. Although neoadjuvant therapy can improve the chances of complete exeresis, not all patients respond as expected.
Detailed description
Pancreatic cancer is an important cause of cancer-related death worldwide. Radical surgical resection still is the only curative treatment option today, but not all tumors are considered resectable. Among resectable tumors, some are deemed borderline and have a high probability of incomplete exeresis. Neoadjuvant therapy (NAT) can be a game-changer for borderline cases, and there is a lack of evidence on the predictive factors associated with resectability after neoadjuvant treatment. This study aims to assess the prognostic factors for resectability and survival after NAT in type A borderline resectable pancreatic ductal adenocarcinoma patients.
Interventions
PROCEDUREResection
Type A BR-PDAC patients who had a favorable tumor/vascular structures relationship confirmed during surgical exploration underwent resection.
PROCEDURENo Resection
Type A BR-PDAC patients who did not have a favorable tumor/vascular structures relationship confirmed during surgical exploration did not undergo resection.
Sponsors
BUSQUETS, JULI
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years old. * Both sexes. * Diagnosed with a type A BR-PDAC between January 2010 and December 2019. * Minimum follow-up period of 12 months.
Exclusion criteria
* Patients diagnosed with a type B or type C BR-PDAC. * Patients diagnosed with a type A BR-PDAC who had disease progression prior to receiving NAT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | From starting NAT until end of the observation period (December 2019) or disease progression (whichever occurs first). | Time until disease progression |
| The number of type A BR-PDAC patients who, after receiving NAT (≥3 cycles), undergo resection. | From 6 weeks until the end of the observation period (December 2019) or death (whichever occurs first) | NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks. |
| The evolution of the plasmatic levels of CA 19-9 from starting NAT until the surgical exploration. | Up to 16 weeks | NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks. |
| The evolution of the degree of vascular involvement in 64-MDCT scans from starting NAT until the surgical exploration. | Up to 16 weeks | We will evaluate the tumor's anatomical relationship with neighboring vascular structures before and after NAT, measured with 64-MDCT (multidetector computerized tomography) scans. NAT was administered up to 6 cycles, and cycles were administered every 2 weeks. The minimum time interval between the last NAT session and surgery was 4 weeks. |
| Overall survival | From starting NAT until the end of the observation period (December 2019) or death (whichever occurs first). | Time until death (from any cause) |
| The evolution of the plasmatic levels of CA 19-9 | From starting NAT until end of the observation period (December 2019) or death (whichever occurs first). | — |
| The evolution of the degree of vascular involvement in 64-MDCT scans | From starting NAT until end of the observation period (December 2019) or death (whichever occurs first). | The tumor's anatomical relationship with neighboring vascular structures; measured with 64-MDCT scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number (percentage) of patients presenting disease progression at the end of the observation period. | From starting NAT until end of the observation period (December 2019) | Disease progression will be considered as the development of metastatic disease and/or an increase in the primary tumor size. |
| The number (percentage) of patients presenting stable disease at the end of the observation period. | From starting NAT until end of the observation period (December 2019) | Stable disease will be considered as an insufficient increase or reduction in the primary tumor size or in its relationship with neighboring vascular structures (i.e., cases that cannot be classified as responders). |
| The number (percentage) of patients considered responders at the end of the observation period. | From starting NAT until end of the observation period (December 2019) | Patients will be considered responders when the primary tumor presents a reduction in size and/or in its relationship with neighboring vascular structures. |
| The number (percentage) of patients surgically explored at the end of the observation period. | From starting NAT until end of the observation period (December 2019) | — |
| The Resection Rate at the end of the observation period. | From starting NAT until end of the observation period (December 2019) | The Resection Rate will be calculated by dividing the total number of resections performed by the total number of patients treated with NAT. |
| The number (percentage) of deaths at the end of the observation period. | From starting NAT until end of the observation period (December 2019) | — |
Contacts
Primary ContactJuli Busquets, MD, PhD
Backup ContactLuis Secanella, MD
Outcome results
None listed